Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker

FDA 510(k) K160915 · Roche Diagnostics

Substantially Equivalent

510(k) numberK160915

Submission

Device name
Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker
Applicant
Roche Diagnostics
Indianapolis, IN, US
Received
April 1, 2016
Decision date
December 14, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OVK – Cytokeratin Fragments 21-1 Eia Kit
Device class
Class II (moderate risk)
Regulation
21 CFR 866.6010
Specialty
Immunology

The CYFRA 21-1 EIA kit is intended for the quantitative determination of soluble cytokeratin 19 fragments in human serum. The assay is to be used as an aid in monitoring disease progression during the course of disease and treatment in lung cancer patients. Serial testing for patient CYFRA 21-1 assay values should be used in conjunction with other clinical methods used for monitoring lung cancer.

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K250925ADVIA Centaur Cytokeratin Fragment 21-1OVK · Traditional Fujirebio Diagnostics,Inc.12/16/2025SE
K100831Cyfra 21-1 Eia Model 211-10OVK · Traditional Fujirebio Diagnostics,Inc.05/26/2011SE

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Questions and answers

When was Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker cleared by the FDA?

Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker (K160915) received a 510(k) decision of Substantially Equivalent on December 14, 2016, 257 days after the submission was received.

What is the product code of K160915?

The FDA product code is OVK – Cytokeratin Fragments 21-1 Eia Kit, a Class II (moderate risk) device regulated under 21 CFR 866.6010.